The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

Phase 4

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Peginterferon alfa

• Registration Number: NCT02745704
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha and NAs.

Detailed Description

In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 weeks.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-17
• Study First Posted: 2016-04-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. CHB patients who had received NAs for more than 12 months.
2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
3. Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
4. Hepatitis B virus DNA not detectable(Roche Cobas).

Exclusion Criteria

1. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
2. Patients with other factors causing liver diseases.
3. Pregnant and lactating women.
4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
5. Patients with diabetes, autoimmune diseases.
6. Patients with important organ dysfunctions.
7. Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
9. Patients who can't come back to clinic for follow-up on schedule.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-IFN group	Peginterferon alfa	Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg \<1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.

Primary Outcome Measures

Name	Time	Method
HBsAg Clearance	72 weeks	Percentage of Participants with HBsAg negative.
HBsAg Seroconversion	72 weeks	Percentage of Participants with HBsAg negative and anti-HBsAg positive.

Trial Locations

Locations (1)

The third affiliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China